Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20.09.1978 - 05.10.1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Remarks:
according to OECD 410, but limited documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Barbituric acid, sodium salt
EC Number:
245-979-7
EC Name:
Barbituric acid, sodium salt
Cas Number:
24012-01-9
Molecular formula:
C4H4N2O3.xNa
IUPAC Name:
sodium 2,4,6-trioxotetrahydro-2H-pyrimidin-1-ide

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
- Fasting period before study: 15-20 h before administration
- Weight at study initiation: 210 - 300 g (males); 180 - 200 g (females)

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
0.5% suspension
Details on oral exposure:
- Concentration in vehicle: 10 and 50 % (w/v)
- Diet (e.g. ad libitum): Herlian MRH-Haltung, Eggersmann KG

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
Doses:
1000 and 5000 mg/kg bw
No. of animals per sex per dose:
5/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: obwervations: 1 h, 1, 2, 7, 14 days; weighing: at the beginning of the study, after 2 to 4, 7 and 14 days
- Necropsy of survivors performed: yes/
- Other examinations performed: clinical signs, body weight, organs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortalities
Clinical signs:
other: orange staining of the urine (high dose level) and diarrhea (both dose levels)
Gross pathology:
Necropsy revealed no findings

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Regulation (EC) 1272/2008
Conclusions:
Single application of 5 000 mg test item per kg bw did not cause lethality in male and female rats during the 14 days observation period, resulting in a LD50 > 5 000 mg/kg bw.
Executive summary:

Male and Female rats were subjected to test acute oral toxicity according to OECD TG 401. The test item was administered at dose levels of 1 000 and 5 000 mg/kg bw to 5 male and 5 female rats respectively. During the 14 days observation period no animals died and there were no abnormalities found in necropsy, thus leading to an LD50 > 5 000 mg/kg bw.